Specific AimsAs reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and there is an urgent need for improvement of current treatment strategies. An innovative, but scarcely examined, treatment option for childhood…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic anxiety disorder status (Diagnostic Interview, T1,2,3,4)
Secondary outcome
Anxiety symptoms (anxiety questionnaire; T1,2,3,4)
Internalising problems (anxiety and depression; T1,2,3,4)
Depression symptoms (T1,2,3, 4)
Quality of Life (T1, 2,3, 4)
Attention bias (T1, 2,3, 4)
Interpretation bias (T1, 2,3, 4)
Parental psychopathology (T1)
Parental anxiety and depression (T1, 2,3, 4)
Parental attention bias (T1, 2,3, 4)
Parenting style (T1, 2,3, 4)
Life events (T1, 2, 3, 4)
Socio-economic Status (T1)
Medical Consumption (T1, 2, 3, 4)
Background summary
Anxiety disorders are the most prevalent psychiatric disorders, occurring in
among 15% to 20% of children. Cognitive behavioral therapy (CBT) is currently
the first-choice treatment for anxiety-disordered children. Despite proven
efficacy, almost half of them do not respond, causing prolonged suffering.
Children with persistent anxiety have an increased risk for other psychiatric
disorders, school dropout, social isolation, alcoholism, and suicide attempts.
Another concern is that only a small proportion of anxiety-disordered children
actually receive treatment. These negative consequences in combination with the
limited accessibility of treatment endorse the urgent need to develop more
effective and accessible treatments that can enhance effectiveness of current
treatment options.
A newly emerging and promising childhood anxiety treatment is Attention Bias
Modification Treatment (ABMT). ABMT is build upon evidence that anxious
children tend to selectively focus their attention on threatening information
in the context of other non-threatening information, and that attention bias is
related to development and maintenance of anxiety disorders. Children with an
attention bias hypervigilantly scan their environment for potential threat or
danger thereby starting a cascade of subsequent processing biases in
interpretation and memory, resulting in heightened anxiety.
Hence, as attention bias is an underlying mechanism of anxiety, treatment that
diminishes attention bias toward threat in anxiety-disordered individuals
should alleviate anxiety. Subsequently, several researchers began to examine
the effect of ABMT, which implicitly trains anxiety-disordered individuals to
attend away from threat toward neutral information. This is a different
approach than CBT, which does not target early and automatic information
processes, but addresses later stages of information processing that are under
volitional control. Several studies highlighted the potential of ABMT in
reducing anxiety levels in adults. A recent meta-analysis revealed that ABMT in
adults produces significantly greater reductions in anxiety than placebo
control training, with a large effect size in clinical populations. Schmidt and
colleagues found that 72% of the adults were free from their primary anxiety
disorder after ABMT as compared to 11% after placebo attention training, which
is far more than CBT. These training effects were maintained at 4-month
follow-up. Importantly, ABMT also modifies neural systems that are involved in
the control of attention to emotional stimuli, in particular the lateral
prefrontal cortex.
Despite the promising results in adults, ABMT has been scarcely examined in
children. Only two studies with small sample sizes have been conducted so far,
one in highly anxious children and the other in anxiety-disordered children.
Both studies demonstrated a significant anxiolytic effect of ABMT, but not of
the placebo control condition. A major limitation of both studies is that
sample sizes were quite low and that a limited number of training sessions were
provided. It has been shown that more training sessions enhance the magnitude
of treatment effect. This is the first study that examines the effectiveness of
a 9-session web-based ABMT in a large sample of anxiety-disordered children as
well as examines the additive effect of web-based ABMT on CBT.
Study objective
Specific Aims
As reviewed above, childhood anxiety disorders are highly prevalent and
debilitating, and there is an urgent need for improvement of current treatment
strategies. An innovative, but scarcely examined, treatment option for
childhood anxiety disorders is ABMT.
The primary aim is to compare internet-ABMT-augmented CBT with CBT as
monotherapy on recovery rates for anxiety disorders and changes in anxiety. The
secondary aim is to compare internet-ABMT with internet placebo attention
training on anxiety disorder recovery rates and changes in anxiety.
Study design
A randomized, placebo-controlled, double-blind trial of web-based Attention
Bias Modification Treatment for childhood anxiety disorders will be conducted.
One hundred twenty-eight children will be randomly allocated to a 9 session
internet-delivered ABMT or placebo attention training.
Children and parents will be assessed before (placebo-)ABMT (T1), after
(placebo-)ABMT (T2), one week after the tenth CBT sessions (T3), and at
6-months follow-up (T4).
Intervention
Internet-ABMT: A trial begins with a fixation cross (+) presented in the centre
of the screen for 500 ms, immediately followed by a stimuli pair consisting of
a neutral and threatening stimulus that is centred horizontally. Stimuli pairs
consist of two faces, pictures or words. After presentation of the stimuli
pair, a probe (: or ..) always appears on the location of the neutral stimulus.
The probe remains on the screen until the participant presses the corresponding
key (: or ..), after which the next trial begins (see figure 1). During each
sessions, participants see 160 trials that comprises various combinations of
probe type (: or ..), probe and stimulus position (left or right), and stimulus
type (faces, pictures or words). Of the 160 trials, 128 trials include one
neutral and one threatening stimulus. The remaining 32 trials include a
neutral-neutral stimuli pair.
Internet-Placebo attention training: The probe appears with equal frequency on
the location of the neutral and threatening stimulus.
All children, regardless of anxiety status after treatment, will receive a
cognitive behavioral treatment (CBT).
CBT: The FRIENDS program is an evidence-based, World Health Organisation
acknowledged, CBT protocol, comprising psycho-education, relaxation, breathing
exercises, exposure, problem-solving skills training, social support training,
and cognitive restructuring training.
Study burden and risks
NUMBER OF ASSESSMENTS AND MEASURES
ADIS-C (anxiety interview; child and parents, 1 hour; T1,2,3, 4)
SCARED-R (anxiety questionnaire, child and parents, 15 minutes; T1,2,3, 4)
CBCL/YSR/RF (internalising problems questionnaires, child and parents and
teacher, 20 minutes, T1,2,3, 4)
CDI (depression questionnaire, child, 10 minutes, T1,2,3, 4)
TACQOL-PF/TACQOL-CF/TAAQOL (quality of life questionnaire, child and parents,
15 minutes, T1,2,3, 4)
Attention bias (computertask, child, 20 minutes, T1,2,3, 4)
Interpretation bias (computertask, child, 15 minutes, T1,2,3, 4)
EMBU-C, EMBU-P (questionnaire parenting style, 15 minutes, child and parents,
T1,2,3,4)
Life events questionnaire (10 minutes, child, T1,2, 3, 4)
SES (social-economic status questionnaire, parents, 10 minutes, T1)
Medical consumption questionnaire (5 minutes, parents, T1, 2, 3, 4)
EXTRA MEASURES WHEN PARENT AS SUBJECT
CIDI (interview psychopathology parents, parents, 1 hour, T1)
ASR (anxiety and depression questionnaire, 15 minutes, parents, T1,2,3, 4)
Attention bias (computertask, parents, 20 minutes, T1,2,3, 4)
RISK ASSOCIATED WITH PARTICIPATION
Negligible for the intervention study. No risk for active paritication of
parents.
Dr. Molewaterplein 60
Rotterdam 3015GJ
NL
Dr. Molewaterplein 60
Rotterdam 3015GJ
NL
Listed location countries
Age
Inclusion criteria
One of the following anxiety disorders as primary diagnosis: specific phobia, separation anxiety disorder, social phobia and generalized anxiety disorder, based on the Anxiety Disorders Interview Schedule for Children (ADIS-C).
Exclusion criteria
IQ below 85, poor command of the Dutch language, serious physical disease, psychosis, substance abuse, pervasive developmental disorder, obsessive-compulsive disorder, posttraumatic stress disorder, acute stress disorder, panic disorder, major depression, serious school refusal, current psychotherapy/anxiety medication, two or more completed cognitive behavioural therapies for anxiety, anxiety treatment in the past six months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL43150.078.13 |